Resistance Exercise and Knee Osteoarthritis Pain, Functional Impairment and Cartilage Turnover

NCT ID: NCT01245283

Last Updated: 2014-12-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2013-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to determine if a 4 month resistance exercise program can reduce knee osteoarthritis pain functional impairment and cartilage turnover.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Knee Osteoarthritis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

knee osteoarthritis pain function impairment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Wait-list Non-exercise Control (CON)

Subjects will continue to participate in their normal activities and clinical care during the four month study period if assigned to this group.

Group Type ACTIVE_COMPARATOR

normal activities and clinical care

Intervention Type OTHER

Subjects will continue to participate in their normal activities and clinical care during the four month study. Telephone contact will be made weekly to encourage adherence to the knee management guidelines

Concentric Focused RX (CRX)

Training protocol for 1 set of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.

Group Type ACTIVE_COMPARATOR

Concentric Focused Resistance Exercise

Intervention Type OTHER

Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.

Eccentric Focused RX (ERX)

The Human Dynamics Laboratory features prototype equipment that increases resistance loads during the eccentric phase of the contraction while "assistance" is provided by the machine during the concentric phase. One set of each exercise - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.

Group Type ACTIVE_COMPARATOR

Eccentric Focused Resistance Exercise

Intervention Type OTHER

Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

normal activities and clinical care

Subjects will continue to participate in their normal activities and clinical care during the four month study. Telephone contact will be made weekly to encourage adherence to the knee management guidelines

Intervention Type OTHER

Concentric Focused Resistance Exercise

Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.

Intervention Type OTHER

Eccentric Focused Resistance Exercise

Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Osteoarthritis (OA) of the knee for \>6 months
* moderate to severe pain immediately following a 50-foot walk
* knee pain primarily due to tibiofemoral OA and not from patellofemoral OA
* bilateral standing anterior-posterior radiograph demonstrating grade 2 or 3 OA of the target knee
* willing and able to participate in regular exercise for four months
* free from musculoskeletal limitations that would preclude resistance exercise participation
* free of abnormal cardiovascular responses during the screening graded maximal walk test

Exclusion Criteria

* unable to walk
* regular resistance exercise training (\>3X week) within the past 6 months
* specific low back pain or acute back injury
* spinal stenosis that precludes walking one block due to neurogenic claudication
* any major injury to either knee within the prior 12 months
* any surgery to either knee within the last 12 months
* lumbar radiculopathy
* vascular claudication
* significant anterior knee pain due to diagnosed isolated patella-femoral syndrome or chondromalacia in either knee
* have had corticosteroid or viscosupplement injections within three months of study participation
* have added new over the counter or prescription pain medication within two months of study participation
Minimum Eligible Age

60 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Florida

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kevin R Vincent, M.D. Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Florida Department of Orthopaedics and Rehabilitaion

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

UF&Shands Orthopaedics and Sports Medicine Institute

Gainesville, Florida, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

614-2009

Identifier Type: -

Identifier Source: org_study_id